Artificial cornea implant aims to reverse blindness in 54-Patient trial

NCT ID NCT07526389

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This clinical trial tests a new artificial cornea (aspheric keratoprosthesis) in 54 adults with severe corneal blindness who cannot have a standard cornea transplant. Participants are randomly assigned to receive either the new device or a control device. The main goal is to see if the implant can restore enough sight to allow independent daily living within 6 months. The study is not yet recruiting and takes place at multiple sites in China.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
artificial cornea implant (aspheric keratoprosthesis)
What this could lead to
If successful, this could provide a new option to restore vision in people with severe corneal blindness who cannot have a standard cornea transplant.
What could go wrong
This is an early-stage trial with only 54 people, so results may not apply to everyone. The implant carries surgical risks like infection or device failure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 54 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18 to 80 years (inclusive), gender unrestricted; 2. Patients with corneal blindness, unable to perform activities of daily living independently, and best-corrected visual acuity \< 0.05 in both eyes; 3. Patients with a high expected risk of failure of allogeneic corneal transplantation or high surgical risk for corneal transplantation; 4. Relatively stable primary ocular diseases, no active purulent infection, and general condition sufficient to tolerate surgery; 5. Normal intraocular pressure, or stable intraocular pressure after treatment for glaucoma (IOP \< 21 mmHg); 6. Normal structure and function of the retina and optic nerve, with preserved visual potential; 7. Willing to participate in this study and have signed the written informed consent form. Exclusion Criteria: 1. Patients with poorly controlled intraocular pressure or requiring IOP-lowering medication, assessed as ineligible for surgery. 2. Patients with active conjunctival infection in the affected eye, assessed as unable to tolerate surgery. 3. Patients with unhealed wound following allogeneic penetrating keratoplasty. 4. Patients with anatomical abnormalities such as eyelid atresia or requiring a prosthetic device to penetrate the skin. 5. Patients with severely impaired retinal or optic nerve function with no potential for visual improvement. 6. Patients with a history of malignant tumor in or around the eye, judged ineligible by the investigator. 7. Patients with intolerance to local anesthetics, mydriatics, or device components, judged ineligible by the investigator. 8. Patients with severe diseases of major organs including heart, liver, and kidney, judged ineligible by the investigator. 9. Patients with severe coagulation disorders, judged ineligible by the investigator. 10. Patients with absolute glaucoma, judged ineligible by the investigator. 11. Patients with severe systemic diseases and a life expectancy of \< 2 years. 12. Pregnant or lactating females. 13. Patients who do not understand the risks of keratoprosthesis surgery, cannot comply with regular follow-up, or fail to administer medication as required. 14. Other patients considered ineligible for this clinical trial by the investigator.

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How to take part

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  1. The official record

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